FDA recall Z-1328-2024

Randox Laboratories Ltd. · Class II · device

Product

Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

Reason for recall

The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

Distribution

Domestic: CA, FL, IL, ME, NJ, OH, & OR.

Key facts

Status
Ongoing
Initiation date
2024-03-01
Report date
2024-03-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2024